Attorney General Ellen Rosenblum announced that a federal judge in Washington state yesterday barred the Food & Drug Administration (FDA) from doing anything to reduce the availability of the early abortion prescription medication, mifepristone, in Oregon, as well as in 16 other states and the District of Columbia. AG Rosenblum and Washington AG Bob Ferguson led the multistate coalition in a lawsuit against the FDA in February, seeking removal of medically unjustified restrictions on mifepristone, an essential medication used for more than half of abortions in the U.S.
The huge victory for the coalition states came only an hour after a federal judge in Texas issued an unprecedented ruling that the same prescription medication, mifepristone, approved by the FDA in 2000 and used safely and effectively by millions of American women since then, will no longer be approved for use in the United States.
“The ruling issued in Texas is a shocking overreach by an anti-abortion judge that threatens the right of women nationwide to make their own decisions about their healthcare and their ability to access medication prescribed by their doctors,” said AG Rosenblum.
“But our win is huge and not to be overshadowed. Our coalition worked around the clock to get the issue of the unwarranted and unlawful Risk Evaluation & Mitigation Strategy (REMS) restrictions on this medication before a federal judge in Washington. The judge not only recognized the irreparable harm that would occur in our states should mifepristone be removed from the market, but also that we are likely to prevail on the merits of the case when it goes to trial.”
“My message to Oregonians: I will fight to the finish line to protect Oregonians’ access to abortion care, including abortion medication. Please don’t lose hope — we will not let up!”
The preliminary injunction in the Washington case preserves access to the abortion medication in the 18 states that sued, and takes effect immediately. The Texas judge’s order is not currently in effect because it gives the FDA a week to appeal, which they have indicated they intend to do.
By way of background, AGs Rosenblum and Ferguson’s lawsuit alleges the FDA singled out mifepristone — one of two medications used in a regimen for early abortions — for excessively burdensome regulation, despite extensive scientific evidence that the drug is safer than other common medications, such as Tylenol.
Of the more than 20,000 drugs approved by the FDA, only 60 — including mifepristone — have extra restrictions known as a Risk Evaluation & Mitigation Strategy, or REMS. Mandatory REMS restrictions, known as Elements to Assure Safe Use (ETASU), are supposed to be reserved for inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others.
The FDA-approved regimen for medication abortion involves a dose of mifepristone, followed by a second drug, misoprostol. To prescribe mifepristone, health care providers must be specially certified by the drug distributor. To receive the prescription, patients and providers must sign an agreement that certifies the patient has decided to take the drugs to end their pregnancy — regardless of whether they are seeking an abortion or are being treated for a miscarriage, which is another common use for mifepristone. A copy of this agreement must be included in the patient’s medical records. To dispense mifepristone, pharmacies must also be specially certified with the drug distributor before they can fill a prescription — a requirement that does not apply to any other drug.
AGs Rosenblum and Ferguson’s lawsuit asserts the restrictions on prescribing and dispensing mifepristone are unduly burdensome, harmful and unnecessary, and expose providers and patients to unnecessary privacy risks. The risks are exacerbated by the growing criminalization and penalization of abortion around the country in the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health. The Dobbs case overturned nearly a half-century of precedent, stripping away the constitutional right to abortion recognized by the court’s Roe v. Wade decision.
In addition to exposing healthcare providers to violence, harassment, or abuse, keeping the REMS restrictions in place unnecessarily impedes access to abortion care in the parts of Oregon where reproductive healthcare is already difficult to obtain. Besides disproportionately impacting rural communities, this burden is especially harsh for patients whose access to healthcare is already diminished by poverty, language barriers, lack of transportation, racial discrimination or other factors.
Yesterday’s ruling by U.S. District Court Judge Thomas O. Rice of the Eastern District of Washington can be found here.